Enzyme is hiring an experienced Software Quality Systems Engineer (Sr or Prin/Mgr, DOE), reporting to the VP of QA/RA, to provide support to Enzyme’s customers in the implementation of Enzyme software/QMS.
The Quality Systems Engineer will also support further eQMS product development by working with the development staff in planning, design, execution, and testing of upgrades as they become available all from the end-user perspective.
May travel to customers. Position allows for flexibility to incorporate the employee’s interests and strengths as Enzyme undergoes significant growth.
This engineer role will:
• In all actions, demonstrate a primary commitment to patient safety.
• Interface with development and regulatory staff and both co-founders.
• Establish and promote a work environment that supports the development of the eQMS and customers.
• Support and interpret the quality system framework in aiding the design evolution of how the QMS is implemented via Enzyme software.
• Apply existing quality management system techniques and procedures with recommendations and implementation of modifications for improved efficiency, compliance, and ability to operate 100% electronically.
• Answer quality management system questions when discussing specific topics with customers.
• Use diplomacy and tact in interactions.
• Assist in the writing of procedures, plans, and even protocols/reports for customer use.
• Support investigations including root cause determinations and documentation of findings as required.
• Interpret and evaluate the analysis in terms of accuracy and precision, and recommend the need for additional actions.
• Assist customers to conduct on-site failure investigations and visits as required.
• Assist customers in conducting internal audits as requested.
• Work cross-functionally in identifying and resolving issues.
A successful candidate will have 5-8+ years experience and complete understanding and wide application of principles theories, and concepts in the field, including minimally 21 CFR 820, ISO 13485, 14971 and 62304.
The Quality Systems Engineer will work under general direction regarding the progress of projects and special assignments. May seek guidance in resolving problems, interpreting established policies, procedures and practices. Expected to grow in the role.
Think TurboTax, but for FDA.
We’re building a software platform to handle the compliance aspects of running a drug or medical device company. Compliance is an ongoing activity for companies in this space, and annual costs per company range anywhere from $100K to $100M. Being deemed not compliant can be devastating, preventing a company from selling any new product for months and sometimes years.
In lieu of hiring costly consultants or employees to address this problem, customers provide our platform access to their data, and the platform outputs documentation in the manner that FDA and other regulatory agencies are looking for.
By using our software platform, customers will cut their annual regulatory costs by 50% (on average) and reduce the risk that their products will not get approved for sale.